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XYLOS™ Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

XYLOS™ Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbialderived cellulose. The device is presented ready-to-use in a sterile double-pouched package. It is intended for one time use.

The provided K100984 510(k) summary for the XYLOS™ Vessel Guard focuses on demonstrating substantial equivalence to predicate devices through material similarity and biomechanical testing, rather than clinical performance based on a study with acceptance criteria often associated with AI/software devices. Therefore, a direct response to some of the specific questions is not possible from the provided text, as they pertain to aspects that are not relevant to this type of medical device submission.

However, I can extract the relevant information and indicate where details regarding AI-specific criteria are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided in the context of this 510(k) submission. The device is a physical implantable sheet, and its substantial equivalence was demonstrated through benchtop biomechanical testing and material comparison, not through a clinical study with a "test set" of patient data or clinical outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable/not provided. Ground truth, in the context of AI or diagnostic studies, refers to a definitive diagnosis or outcome, usually established by experts. For this device, "ground truth" would relate to the established material properties and biomechanical performance standards of the predicate devices. These are typically assessed by engineers and materials scientists in laboratory settings.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth in clinical or image-based studies. Since this submission relies on benchtop testing and material comparisons, such adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpreting data or images. The XYLOS™ Vessel Guard is an implantable surgical aid, and its effectiveness is demonstrated through its physical properties and biological compatibility, not through an assessment of human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This concept applies to AI algorithms that operate independently. The XYLOS™ Vessel Guard is a passive physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Established Material Composition: The chemical and biological identity to the predicate MTA™ Protective Sheet.
• Established Biomechanical Performance Standards: The tensile strength and suture pull-out performance as demonstrated by the predicate devices (Replication Medical Vessel Guard, PRECLUDE® IMA Sleeve, PRECLUDE® Vessel Guard).

Essentially, the ground truth for this submission is the well-characterized properties and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" applies to machine learning or AI models, where data is used to teach the algorithm. This device is a physical product, not an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as #8.

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